Duns Number:832696038
Device Description: VITAL SAROT NEEDLE HOLDER STRAIGHT JAWS, SERRATED TUNGSTEN CARBIDE INSERTS OVERALL LENGTH VITAL SAROT NEEDLE HOLDER STRAIGHT JAWS, SERRATED TUNGSTEN CARBIDE INSERTS OVERALL LENGTH 7-1/8"(18.1CM)
Catalog Number
CH2416
Brand Name
V. Mueller
Version/Model Number
CH2416
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MDM
Product Code Name
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Public Device Record Key
29efcd83-1986-4046-bc1a-59849d49f096
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
August 09, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |